Health Condition 1: null- Diabetic patients with Diabetic Macular Edema
Conditions
Interventions
Intervention1: Vidangarajanyadi Kashaya (Ayurvedic formulation): 500 mg extract (1 capsule) of Vidangarajanyadi Kashaya twice in a day for 6 months
Control Intervention1: Placebo (Starch Capsules): 25
Sponsors
Ruby Kumar
Eligibility
Inclusion criteria
Inclusion criteria: At least one eye must meet all of the following criteria: a) Patients equal to or more than 18 years of age, diagnosed with Type 2 diabetes mellitus having decreased vision due to macular edema associated with non-proliferative (mild to moderate) diabetic retinopathy (DR). b) Patients with severe non-proliferative DR not willing to receive any conventional therapy for diabetic macular edema during next 6 month. c) Diagnosis of diabetes mellitus (Type 2) - Any one of the following will be considered to be sufficient evidence that diabetes is present: - Current regular use of insulin for the treatment of diabetes - Current regular use of oral antihyperglycemic agents for the treatment of diabetes - Documented diabetes by WHO guidelines d) Best corrected ETDRS visual acuity score equal to or more than 34 to 76 letters (approximately 6/9 to 6/60 Snellen equivalent). e) Definite central retinal thickening of equal to or more than 300 μm due to diabetic macular edema detected by spectral domain OCT examination. f) Patients able and willing to provide informed consent. g) No expectation that subject will be moving out of the area of the study center during the next 6 months.
Exclusion criteria
Exclusion criteria: a) Patients of diabetic macular edema associated with Type I diabetes mellitus and with Proliferative DR. b) Patients with severe non-proliferative DR willing to go for any conventional therapy for diabetic macular edema. c) Conditions that would preclude participation in the study (e.g. unstable medical status including blood pressure and glycemic control) - Patients in poor glycemic control who recently initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 6 months. d) Patients treated with focal/grid laser within 6 month, intravitreal Anti-VEGF injections within 3 month and intravitreal steroid within 6 months of study entry, history of intraocular surgery within 90 days before study entry. e) Macular edema is not considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible (i) if the macular edema is considered to be related to cataract extraction or (ii) clinical exam and/or OCT suggests that vitreoretinal interface disease (e.g. vitreo-retinal traction or epiretinal membrane) is the primary cause of the macular edema. f) Ocular condition (other than diabetes) that might affect macular edema or alter visual acuity (e.g. vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome). - Glaucoma per se is not an exclusion. g) An ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition). h) Patients with a history of acute coronary event or stroke, renal failure, pregnancy or lactation. i) Media clarity, pupillary dilation, and patient cooperation insufficient for adequate fundus and OCT examination. j) Active participation in any type of intervention study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. To determine the change in macular retinal volume measured by optical coherence tomography (OCT). b. To determine the change in central retinal thickness measured by optical coherence tomography (OCT).Timepoint: 3 month, 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the change in best corrected visual acuity measured by ETDRS method.Timepoint: 3 month, 6 month | — |
Countries
India
Contacts
Public ContactRuby Kumar
Institute of Medical Sciences, Banaras Hindu University
Outcome results
None listed